About The Company

ADVANCED CLINICAL TRIALS is a Clinical Research Organization that has been providing clinical services for the pharmaceutical and medical devices industry since 2008.

Our activities are mainly focused on phase II-IV clinical research in any therapeutic area, including local preliminary trials, multi-center international trials, as well as post-marketing and observational studies. We also offer our customers professional project management and consulting services.

Our experienced and highly professional team is personally committed to adjust our ‘bespoke’ services to answer each and every Client’s need. Thanks to the long term experience and flat structure of the company we are very flexible and personally involved in every project. We are perfect partner for highly specialized, complicated trials in special populations, with difficult recruitment and challenging conditions.

We are proud of the highest recruitment rates in Europe in many trials while achieving excellent audits results.

The founder and head of ACT is Krystyna Iwińska, physician with over 20 years of experience in academic research, clinical trials monitoring and management.

We are the members of the Polish Association for Good Clinical Practice (GCPpl Association).

Clinical Services

Project set up

ACT provides a wide range of services concerning study set up and submission. We translate all kinds of documents (e.g. patient information and consent, other patient materials, laboratory guidelines, etc.) and adapt them to the Polish law. We take responsibility for collecting appropriate documentation and submitting studies to the relevant authorities, in order to obtain the required approvals without delay. We ensure professional supervision of the whole process as well as efficient communication between the authorities and the sponsor.

eCRF and data management

In cooperation with our partners in business we offer eCRF design and development, data management and statistical services.

Feasibility

We understand how important is the right choice of an investigative center and qualified personnel, so we pay great attention to the feasibility process as a powerful tool for site and staff suitability verification.

Site selection

Considering the feasibility process and our experience, we are able to identify the weak and strong points of potential study sites, suggest the best centers for specified profile of the study and provide a suitable approach for each of the chosen centers.

Budget planning

Having years of experience ACT can offer customers support with study budget planning, taking into consideration all aspects of the study including local conditions, constraints and realities.

Contracts

We have a wide experience in preparing and executing contracts with sites, hospital authorities, investigators, other site staff and involved third parties. We take responsibility for all activities and communication, which includes respecting deadlines with regards to signing all documents needed for study submission and start. We are also experienced with handling confidential information, protecting our sensitive data and respecting fair competition law.

Investigators training

In cooperation with our partners in business, we organize local and international meetings, where we provide appropriate training and information to all parties involved in the trial. This includes protocol, Good Clinical Practice, study of specific procedures, data capture and all other kinds of training according to the sponsor requirements. We also consider an initiation visit as a very important tool for advanced training on the study procedures for all site staff, in order to ensure that the trial is carried out smoothly and efficiently.

Study monitoring

ACT personnel consists of well educated professionals with excellent interpersonal skills and high level of responsibility. We pay great attention to regular staff training in order to meet international standards. All personnel involved in the trial receives study-specific training and sponsor SOP training before the beginning of the project.

Project management

Our experience in project management allows us to keep supervision over any step of the study and to monitor all activities of the parties involved. We are eager to cooperate closely with the study sponsor, in order to respect the study timelines and budget.

Comprehensive Services

Clinical trial nursing services

Together with our business partner we can provide clinical trial visits in the patient’s home and supporting clinical trial sites with nursing resources in several EU countries.

Medical devices registration and trials

ACT offers comprehensive legal assistance and submission to relevant institutions for companies from the EU as well as from outside, wishing to introduce medical devices to the market. We help you to prepare necessary documents and register your product with the Polish regulatory authorities.

Investigators and site staff payments

We supervise the process of investigators and site staff fee payments and provide sites and sponsor with updated information and payments record.

Reimbursement of patient’s travel costs

We provide full management of patient’s travel and accommodation costs reimbursement, according to Polish regulations in force and customer’s requirements.

Audits

We believe that the quality in clinical operations is of the highest importance. That is why we propose our services to prepare for an audit of all clinical studies conducted at research site or other quality-related activities, in accordance with our customer’s needs and worldwide standards.

Logistics services

In cooperation with our partners in business we offer clinical packaging and labelling, qualified transport and destruction of medicinal products in accordance with GMP and GDP.

Therapeutic Areas

ACT can undertake projects in any therapeutic area. So far we have worked in:

Our Team

Our experienced team of professionals is dedicated to you needs

ACT management

Krystyna IwińskaOwner and Managing Director

Krystyna is founder and head of ACT. She is a physician with over 20 years of clinical trials experience and academic background in pre-clinical trials. She gained experience in clinical trials as CRA at Synthélabo Recherche, Parexel and then was the Medical Advisor and subsequently Clinical Research Manager at Yamanouchi/Astellas. Her responsibilities included management of international projects in Central Europe.

Jacek TworzowskiClinical Operations Manager

Jacek has gained over 20 years of business experience in the largest international CRO and FMCG companies. For over 10 years he is in clinical research working for numerous Sponsors as e.g.: Roche, GSK, Reliance Genemedix, Toray Industries Inc. He is ACT associate from very beginning. He has academic background in life sciences (MSc in Rehabilitation).

References

We have successfully conducted numerous CRO assignments for renowned pharma companies and results
of our full commitment were always reflected in the feedback we received.

I wish to congratulate you on these results and thank you very much,
for it is largely to your merit. I am glad to have the opportunity to work with you.

Study Manager, Roche

I have had the opportunity to work with a wide variety of Trial Managers and CROs.
However, support I have experienced from ACT in last clinical trial is inappreciable.

Dr Konrad Futyma, Top-recruiting Investigator

We are very satisfied with our cooperation with ACT.
They are client-focused, ensure timely execution of process and act in a very professional manner.

President, Pharmnew

Their high professionalism, interpersonal skills and commitment distinguish ACT among other CROs.